Anesthesiology
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- MiscellaneousMiscellaneous
- QHGDefect Measurement Tool2Product Code
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices2Product Code
- QLRManual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices2Product Code
- NQOProsthesis, Spinous Process Spacer/Plate3Product Code
- HTMStimulator, Osteogenesis, Electric, Battery-Operated, Invasive3Product Code
- HWFProsthesis, Ligament3Product Code
- LMLLigaments And Tendons, Synthetic3Product Code
- LMNCeramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses3Product Code
- LOEStimulator, Invasive Bone Growth3Product Code
- LOFStimulator, Bone Growth, Non-Invasive3Product Code
- LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented3Product Code
- LPQStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep3Product Code
- LWAProsthesis, Ligament, Ptfe3Product Code
- LXCMonitor, Pressure, IntracompartmentalUProduct Code
- LXYProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer3Product Code
- LZJProsthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-ConstrainedUProduct Code
- MBDProsthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer3Product Code
- MBJFastener, Fixation, Biodegradable, Hard Tissue3Product Code
- MBSFiller, Bone Void, Non-Osteoinduction3Product Code
- MCVSpinal Pedicle Screw, Fixation, Appliance System3Product Code
- MDIProsthesis, Rib ReplacementUProduct Code
- MJOProsthesis, Intervertebral Disc3Product Code
- MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented3Product Code
- MOZAcid, Hyaluronic, Intraarticular3Product Code
- MPKSemi-Constrained Metal/Polymer Finger Joint ProsthesisFProduct Code
- MPWFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction3Product Code
- MQOProsthetic Disc Nucleus DeviceNProduct Code
- MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3Product Code
- MRWSystem, Facet Screw Spinal DeviceUProduct Code
- NBNGenerator, Shock-Wave, For Pain Relief3Product Code
- NCOImplant, Cartilage, For Articular Cartilage Repair3Product Code
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis3Product Code
- NEKFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction3Product Code
- NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NOXFiller, Bone Void, Synthetic Peptide3Product Code
- NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing3Product Code
- NTGProsthesis, Ankle, Uncemented, Non-Constrained3Product Code
- NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarUProduct Code
- NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing3Product Code
- OJZFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - HdeFProduct Code
- OKDFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone NonunionFProduct Code
- OMEExtracorporeal Shock Wave Treatment3Product Code
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisFProduct Code
- OVOProsthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation3Product Code
- OYRFiller, Bone Void, Recombinant Platelet-Derived Growth FactorNProduct Code
- PBUBone Void Filler, SyringeNProduct Code
- PFMHemibridge SystemNProduct Code
- PGMGrowing Rod SystemUProduct Code
- PGNGrowing Rod System- Magnetic ActuationUProduct Code
- PIXElbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented ProsthesisNProduct Code
- PJYOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees3Product Code
- PNWProsthesis, Metatarsophalangeal Joint Cartilage Replacement Implant3Product Code
- PWGSpinal Fixation SystemNProduct Code
- QCGFiller, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow LesionsNProduct Code
- QESReherniation Reduction Device3Product Code
- QGPPosterior Ratcheting Rod SystemNProduct Code
- QHPVertebral Body Tethering SystemNProduct Code
- QNNTalus SpacerFProduct Code
- QRRFiller, Bone Void, Calcium Compound Containing Gentamicin2Product Code
- QJDAbsorbable Metallic Bone Fixation Fastener2Product Code
- QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis2Product Code
- QVVMedial Knee Implanted Shock Absorber2Product Code
- QWLIntraoperative Surgical Angle Measurement Tool2Product Code
- QRUImplant, Resorbable, For Articular Osteochondral Repair3Product Code
- QWKProsthesis, Posterior Spinal Elements3Product Code
- QYQProsthesis, Total Talus Replacement With Soft Tissue Attachment Sites, MetalFProduct Code
- QZOWearable Vibration Device For Orthopedic Use2Product Code
- QZYSpinal Fusion Device With Quaternary Ammonium Compound Coating2Product Code
- QZZLimb And Joint Salvage Device With Coating For Bacteria Reduction2Product Code
- Submissions with No Product CodeMiscellaneous
- K243461Calibrate Interbody SystemsCleared 510(K)
- K242307ACHIEVE Partial Knee SystemCleared 510(K)
- K243408TACTIX Vector Syndesmosis SystemCleared 510(K)
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesCleared 510(K)
- K864488SWANSON TITANIUM CONDYLAR IMPLANTCleared 510(K)
- K870213MODIFIED PROFILE FEMORAL HIPCleared 510(K)
- K870174MCCUTCHEN FEMORAL HIP PROSTHESISCleared 510(K)
- K862755DUNN ANTERIOR DISTRACTION SYSTEMCleared 510(K)
- K864331TRI-LOCK LONG STEM MODULAR NECKCleared 510(K)
- K864788EXACTECH TOTAL HIP INSTRUMENTSCleared 510(K)
- P830055LCS® Total Knee SystemOK30PMA Approval
- P960047HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERTAPPRPMA Approval
- P970015INTERFIX THREADED FUSION DEVICEAPPRPMA Approval
- P970015INTER FIX THREADED FUSION DEVICEAPPRPMA Approval
- P970015INTER FIX III THREADED FUSION DEVICEAPPRPMA Approval
- P960047OSTEONICS CONSTRAINED ACETABULAR INSERTAPPRPMA Approval
- P970015INTER FIX RP THREADED FUSION DEVICEAPPRPMA Approval
- P970015INTER FIX THREADED FUSION DEVICEAPPRPMA Approval
- P970015INTER FIX RP THREADED FUSION DEVICEAPPRPMA Approval
- P970015INTER FIX THREADED FUSION DEVICEAPPRPMA Approval
- P970015NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD)APPRPMA Approval
- P970015NOVUS (TM) LC INTERBODY FUSION DEVICEAPPRPMA Approval
- P960047OSTEONICS CONSTRAINED ACETABULAR INSERTAPPRPMA Approval
- K863271FASCICULATED S RODCleared 510(K)
- K863239FASCICULATED BOAT RODCleared 510(K)
- K863215FASCICULATED I RODCleared 510(K)
- K864631MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.Cleared 510(K)
- K864337SEGMENTAL SPINAL INSTRUMENTATION SYSTEMCleared 510(K)
- K864508HOWSE II TOTAL HIP REPLACEMENT SYSTEMCleared 510(K)
- K864372OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACECleared 510(K)
- K864423RAYLOR(TM) OSTEOTOMESCleared 510(K)
- K864340WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTSCleared 510(K)
- K863896AUSTIN MOORE HIP PROSTHESISCleared 510(K)
- K863854P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUGCleared 510(K)
- K863554THACKRAY CRUCIATE SPARING KNEE CS-1Cleared 510(K)
- K863528BICONDYLAR TOE PROSTHESISCleared 510(K)
- K862157OMC ORTHOMET CANNULATED SCREWCleared 510(K)
- K862945DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATESCleared 510(K)
- K861183INTRAMEDULLARY RODCleared 510(K)
- K862752C.S.M. HIPCleared 510(K)
- K861826KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEMCleared 510(K)
- K861450SCHURMAN/CARTER HIP PROSTHESIS POROUS COATEDCleared 510(K)
- K860207S-ROM 135 POROUS COATED FEMORAL STEM COLLARCleared 510(K)
- K860163BICONDYLAR TOE PROSTHESISCleared 510(K)
- K861292CASTALERTCleared 510(K)
- K861043SPINAL EXCURSION METERCleared 510(K)
- K854621ISOSTATION KNEE MACHINE (K-100)Cleared 510(K)
- K854943OMKNEE SYSTEM, POROUS COATEDCleared 510(K)
- K855148THARIES FIBERCleared 510(K)
- K852137FENLIN TOTAL SHOULDERCleared 510(K)
- K860074SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESISCleared 510(K)
- K855123KMW HIP PROSTHESIS POROUS COATEDCleared 510(K)
- K851864SPINAL STABILIZING UNITCleared 510(K)
- K851409UNILOC TOTAL HIP PROSTHESISCleared 510(K)
- K854248GOODLEY POLYAXIAL CERVICAL TRACTION UNITCleared 510(K)
- K854191MECRON UNCEMENTED STRUCTURED STEM HIPCleared 510(K)
- K853437H-H HUNTER TENDON RODCleared 510(K)
- K853764TENDON LEADERCleared 510(K)
- K853205PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIPCleared 510(K)
- K850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETCleared 510(K)
- K851206SHOULDER-HOLDERCleared 510(K)
- K843013H-H TENDEON IMPLANTCleared 510(K)
- K843778MAYO ELBOW IICleared 510(K)
- K842626HIP PROSTHESIS PACKCleared 510(K)
- K841517CLOUTIER II TOTAL KNEE W/BEADED SURFCleared 510(K)
- K840271CEMENTLESS HIP PROSTHESISCleared 510(K)
- K841022SRC TOTAL KNEECleared 510(K)
- K841300ANTRUM NEEDLE-WOLF TYPECleared 510(K)
- K841125HUCKSTEPS STAPLESCleared 510(K)
- K833461HS4 HEAD/NECK FEMORAL PROSTHESESCleared 510(K)
- K832740FEMORAL FRACTURE ORTHOSISCleared 510(K)
- K831708MICRO-STRUCTURED SURFACE HIP PROSTHESISCleared 510(K)
- K831426ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTSCleared 510(K)
- K823059DOSIMETRY RELEASE OF RADIATION STERIL.Cleared 510(K)
- K820218PRE-STERILIZATION OF VITALLIUM ALLOYCleared 510(K)
- K820899MECRON VOORHOEVE TITANIUM SHEATHCleared 510(K)
- K820958DIGILOG SYSTEMCleared 510(K)
- K820719THE ICR KNEECleared 510(K)
- K813094ACETABULAR CEMENT COMPRESSORCleared 510(K)
- K812440POWER PACKCleared 510(K)
- K812439DUAL MPC CHARGERCleared 510(K)
- K811961VISITEC NEEDLE RANGE (ORTHOPAEDIC)Cleared 510(K)
- K811119WEBER/STUEHMER HIP JOINT ENDOPROSTHESISCleared 510(K)
- K811201EFTEKHAR ACETABULAR STANDOFFCleared 510(K)
- K810644HOFFMAN HOOP DEVICECleared 510(K)
- K810518CAST HIPPED VITALLIUMCleared 510(K)
- K803093SLIT CATHETER SYSTEMCleared 510(K)
- K803029TLC SUPPORT PRODUCTSCleared 510(K)
- K802106LEWIS TRAPEZO METACARPAL PROSTHESISCleared 510(K)
- K801934WORRELL PATELLA FEMORAL SHIELDCleared 510(K)
- K801313COMPRESSION MOLDING OF UHMWPECleared 510(K)
- K800948DOODLE BRUSHCleared 510(K)
- K791757CERVICAL ORTHOPEDIC PILLOWCleared 510(K)
- K781937PROTHESIS, METACARPALCleared 510(K)
- K781343RESURFACE PROSHESISCleared 510(K)
- K781135INGROWN TOENAIL APPLIANCE, ORCleared 510(K)
- K781112CAST WEDGE, YANCEYCleared 510(K)
- K770856PROSTHESIS, TRAPEZIUM & TRAPEZIUM TRIALCleared 510(K)
- K770501KNEE CUFF FOR EXPRESSING FLUIDCleared 510(K)
- K770124PRE-ROLLED IMPERVIOUS STOCKINETTECleared 510(K)
- K770079KESSELL TOTAL SHOULDERCleared 510(K)
- K761222BENZOIN ISOBUTYL ETHERCleared 510(K)
- K761092INGUINAL COMPRESSIVE DEVICE (ICD)Cleared 510(K)
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
THE ICR KNEE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K820719
- 510(k) Type
- Traditional
- Applicant
- AMERICAN ORTOMED CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/12/1982
- Days to Decision
- 57 days